Events

Retiro De Equipo (Recall) de Smith & Nephew Renasys Transparent Film and Renasys Gauze Dressing Kits NPWT Wound Sealing Kit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20501
  • Fecha de inicio del evento
    2016-08-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Ltd, Unit A, 36 Hillside Rd, Wairau Walley, Auckland 0627
  • Causa
    The manufacturer has identified seal integrity failures on the folded sterile renasys™ transparent film pouches during transit testing. all the seal integrity failures identified during the testing occurred at the point where the sterile renasys™ transparent film pouches were folded during the packaging process.
  • Acción
    Product to be returned to supplier

Device

Smith & Nephew Renasys Transparent Film and Renasys Gauze Dressing Kits NPWT Wound Sealing Kit
  • Modelo / Serial
    Model: , Affected: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc